how to read and write a q report

8/12/2019 How to Read and Write a Q Report

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How to read and write a quality

control reportAlongside efficacy and safety, the quality of new and

marketed drug products is one of the predominant

requirements laid down by the rules governing drug

manufacture and approval of new medicines.

Quality Control(Drug monitoring):

All measures taken, including the setting of specification

sampling, testing and analytical clearance, to ensure that raw

materials, intermediates, packaging materials and finished

pharmaceutical products conform with establishedspecifications for identity, strength, purity and other

characteristics.Quality control (QC)has to ensure the constant reproducible

characteristics of drugs in all parts of the world in order to

guarantee pharmacodynamic effects in all patients. QC plays an

important role in exactly elaborating, defining and refining quality

specifications and appropriate testing methods. There is a

long-established approach to compiling the specifications ofpharmaceutical products employing official methods including

pharmacopoeial methods, validated analytical procedures

provided by the manufacturer and approved by the relevant

government or validated analytical procedures developed by the

laboratory.National pharmaceutical quality control

laboratories:

The government, normally through the national

medicines regulatory authority (NMRA)-in Egypt the ministry

of health -must establish a pharmaceutical quality control

laboratory to carry out the required tests and assays to verify


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that pharmaceutical active ingredient, excipients and final

products meet the prescribed specifications.

Throughout the process of marketing authorization and post

marketing surveillance, the laboratory work closely with the

NMRA.A national pharmaceutical quality control

laboratory:provides effective support for NMRA acting together with

its inspection services. The analytical results obtained should

accurately describe the properties of the samples assessed,

permitting correct conclusions to be drawn about the quality

of the samples of medicines analyzed, and also serving as anadequate basis for any subsequent administrative regulations

and legal action.The laboratory, or the organization of which it is part,

should be an entity that is legally authorized to function and

can be held legally responsible.

To ensure patient safety,the role of the nationalpharmaceutical quality control laboratory should be defined

in the general pharmaceutical legislation of the country insuch a way that the results provided by it can, if necessary,

lead to enforcement of the law and legal action.

National pharmaceutical quality control

laboratories usually encompass essentially

two types of activity:1- Compliance testing of active ingredient, pharmaceutical

excipients and pharmaceutical products.2- Investigative testing of suspicious, illegal, counterfeit

substances or products, submitted for examination by

medicine inspectors, customs or police.


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Quality control laboratories of a manufacturer:-Each company or factory of pharmaceutical

products must establish a quality control laboratory for self

inspection and monitoring each product batch before

marketing .Marketing authorization (product license,

registration certificate):A legal document issued by the competent medicines

regulatory authority that authorizes the marketing or

distribution of a new pharmaceutical product in the

respective country after evaluation for safety, efficacy and

quality. In terms of quality it establishes the detailedcomposition of the pharmaceutical product and the quality

requirements for the product and its ingredients. It also

includes details of packaging, labeling, storage conditions,

shelf-life and approved conditions of use.Quality control reportQuality control report is the report presented by the responsible

authorities quality control unit at the pharmaceutical productfactory or by the quality control laboratory of the ministry of

health.Quality control report is considered the passport for any

pharmaceutical product to be delivered to the market. Quality

control report is written by the responsible pharmacist.

The typical structure of the quality control reportQC report must contain the following parts:-

1-The title of the quality control laboratory :

a-In case of pharmaceutical product factory :

the name of the factory , the name of the unite of drug

analysis , the name of the department

b-In case of the quality control laboratory of the ministry

of health:the name of ministry of health, the name of the


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unite of drug analysis, the name of the department2-The address of the quality control laboratory ,

telephone number(s),fax number,......

3-The report number. 4-The date of the report.5-Analytical test report:-(SAMPLE INFORMATION)

A-PHYSICAL/VISUAL INSPECTION TEST1- Labeling requirements:-

-Brand Name of the drug sample.-Generic name of active ingredient(s).

-Dosage form and strength.

-Name of reference standard used (as claimed on label

e.g. USP, BP, IP, EP).

-Manufacturers Batch or Lot Number.- Name of manufacturer and address (with

telephone and fax numbers).

-Manufacturing date.

-Expiry date.

-Storage conditions.

- Registration or licensed number.2- Sampling requirements:-

-Name and address (with telephone and fax number, of

location/place where sample was collected.

-Date when the Lab receives sample.

-Name of test requester or sender of the

sample/date/sign.

3- Packaging:-

-Material (blister pack/card, bottle, others specify).-Unit dose per blister card or container stated.

-Any print on the packing foil (if packed in blister

pack or card).

4-Description of dosage form:-


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-Shape (circular, oval, flat sides , liquid , suspension,other)

-Uniformity of shape.

-Uniformity of color

-No physical damage (cracks, breaks, erosion,

abrasion, sticky).

-Other observations (no foreign contaminant,

dirty marks, proper seal - for capsule).B-DISINTEGRATION TEST (IF TESTED)

Did the drug pass observed disintegration test?

Time of complete disintegration-----------------

C-DISSOLUTION TEST(IF TESTED, SPECIFY METHODOR PROCEDURE AND ACCPETANCE CRITERIA:

Result: --------------------------------------------------------------------

Passed Failed

D-HARDNESS TEST (IF TESTED)Result:

--------------------------------------------------------------------E- OTHER TEST USED FOR VERIFICATION

AND IDENTIFICATION OF CONTENT OF

ACTIVE INGREDIENTSpecify the test method(s) and reference to a pharmacopeial

monograph

------------------------------------------------------------------

--------------------------------------Name of PAI(s):1-

2-..


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Identification results: Present---------------------------

Not present---------------------

Assay for contentName of PAI (S)1.......................................................

2........................................................

Acceptance criteria....................................................

.

Results------------------------------------------------------------------------------

-----------------------------------------------------

----------------------------------------------------------------------

F-FINAL COMMENTSThe sample meets standards

The sample does not meet standards

(Reason:.. .)

The sample is doubtful for its quality testing

(Reason:.......)and further testing is needed at a reference lab)

REPORT PREPARED BY:Date: ....

Name:.

Signature:

REPORT REVIEWED BY:

Date : .Name:

Signature :..


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B-ACTION TO BE TAKEN BY THE QC LAB*1. Report to responsible authorities:

Report is writing to e.g. MOH Drug Regulatory

Authority :Date and sign

2.Bureau of Drug and Narcotics Lab.

3. National Institute for Drug Quality Control.

Send to:

-USP Lab- Send samples to the Reference Lab for confirmatory

testing.

( They should always be accompanied by a Request Form)Date:.

Signature:.

* Action to be taken and communication between key

agencies in the country should be dependent on individual

country setting.

Exercise:--From your home ,bring a package of any pharmaceutical

product.

-Make a quality control report for this sample.

-Work individually.

how to read and write a q report

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